NeuroHealing Pharmaceuticals Announces Publication Supporting the Use of NH001 to Treat Patients in a Coma and Issuance of NH001 Patent
April 14, 2010 (PRLEAP.COM) Health NewsNewton, Massachusetts – April 14, 2010 – NeuroHealing Pharmaceuticals, a private, clinical stage company developing innovative drug treatments for specialty indications based on repositioning neurologically active compounds, announces the publication of a scientific article in the journal Brain Injury, supporting the use and further development of NH001 for the treatment of patients in a coma.
The article (Fridman, et al, "Continuous subcutaneous apomorphine for severe disorders of consciousness after traumatic brain injury," Brain Injury, April 2010; 24(4): 636–641) describes the results of a clinical study of the efficacy and safety of administration of apomorphine in patients in a vegetative state or minimally conscious state due to severe traumatic brain injury.
The results demonstrate an improvement in the primary outcomes for all patients. Awakening was seen as rapidly as within the first 24 hours of drug administration and as late as 4 weeks. All patients who completed treatment completely recovered consciousness and improvements were sustained for at least one year, even after drug was discontinued. The authors conclude that based on this pilot study, apomorphine infusion appears to be feasible, safe and potentially effective in improving consciousness in patients in a vegetative or minimally conscience state due to a severe traumatic brain injury.
NeuroHealing further announces that the Canadian Intellectual Property Office has issued Canadian Patent number 2,519,117 entitled "High Potency Dopaminergic Treatment of Neurological Impairment Associated with Brain Injury." NeuroHealing filed and fully owns all rights to this patent with an expiration date of March 2024. This patent discloses methods and compositions based on apomorphine for the treatment of an individual in a coma, vegetative state or minimally conscious state who has sustained a brain injury. Patents in the United States and Europe are pending.
NH001 is a potent dopaminergic agonist with well-established human safety data, appropriate pharmacokinetic profile and convenient route of administration. It is a direct acting dopamine agonist on both D1 and D2 dopamine receptors. It rapidly crosses the blood brain barrier and reaches a concentration in the brain eight times higher than that in plasma. Because dopaminergic function appears to be of importance in executive central nervous system function, such as arousal and memory, NH001 has been designed to help regain consciousness, accelerate recovery and improve the functional outcome of patients from a coma, vegetative or minimally conscious state following a traumatic brain injury. The first clinical site of a U.S. double blind Phase II clinical trial is the Spaulding Rehabilitation Hospital (Harvard Medical School affiliate) in Boston under funding by a clinical grant from the FDA's Office of Orphan Drug Products.
About Coma, Vegetative State and Minimally Conscious State
Each year in the U.S. 25,000 to 50,000 patients survive a severe TBI but remain in an altered consciousness state – such as coma, vegetative state and minimally conscious state – for an extended period of time. These 'altered consciousness states' are characterized by the lack of awareness and lack of interaction with the environment. Diffuse axonal injury, a neural pathology occurring in post-TBI patients, is associated with a disruption of dopamine pathways. There is evidence suggesting that dopamine agonists may have a role in regaining consciousness, facilitating rehabilitation and improving outcome. In the acute stage, the main medical efforts are focused on stabilizing vital signs, internal homeostasis and intra-cranial pressure. After the patient reaches stability, current therapy is based on sensory stimulation. There are no approved drug treatments for post-traumatic patients who remain in a vegetative state or minimally conscious state.
About NeuroHealing Pharmaceuticals
NeuroHealing Pharmaceuticals, Inc. is a clinical stage private company developing innovative treatments for specialty indications based on repositioning neurologically active compounds. Clinical stage programs include: NH001 (phase II), a dopaminergic agent to help post traumatic brain injury patients to emerge from a coma, vegetative or minimally consciousness state; NH004 (phase II), an anticholinergic agent in a convenient intra-orally muco-adhesive dissolving film to help treat motor neuron disease patients who suffer from sialorrhea (drooling); and NH02D, a neurologically active compound to treat premature ejaculation.
NeuroHealing Pharmaceuticals, Inc.
Daniel Katzman, President